Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit in Treating Patients With Adhesive Capsulitis

Taipei Veterans General Hospital

Status: Enrolling

Conditions: Adhesive Capsulitis of Shoulder

Treatments: Drug: axillary nerve injection; Drug: steroid hydrodilatation

Study type: Interventional

Funder types: Other

Identifiers

NCT05921539

2021-02-011B

Details and patient eligibility

About

This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus hydrodilatation with steroid with axillary nerve injection for treating patients with adhesive capsulitis.

Full description

Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis.

Design: a prospective, single-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided hydrodilatation with steroid via posterior approach) and group 2 (ultrasound guided hydrodilatation with steroid via posterior approach as well as axillary nerve injection). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, and Shoulder Pain And Disability Index.

Enrollment: 72 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 35-65 years (to prevent the inclusion of patients with secondary AC),
2. onset of shoulder stiffness since over a month
3. limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion criteria

1. ultrasound findings of rotator cuff tears
2. plain radiography findings of significant glenohumeral joint arthritis
3. accompanying cervical radiculopathy
4. systemic inflammatory joint disease
5. intra-articular injection into the glenohumeral joint within the past 3 months
6. history of surgery on the affected shoulders
7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids
8. allergy to corticosteroid or lidocaine. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

hydrodilatation and axillary nerve injection

Experimental group

Description:

patient received ultrasound-guided steroid hydrodilatation via posterior recess

Treatment:

Drug: steroid hydrodilatation

Drug: axillary nerve injection

hydrodilatation only

Active Comparator group

Description:

patient received ultrasound-guided steroid hydrodilatation only

Treatment:

Drug: steroid hydrodilatation